A Multicenter, Randomized, Double-Masked Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.59 and 2.1 mg) Implant in Patients with Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Bausch & Lomb (Rochester)0 个研究点目标入组 40 人开始时间: 2005年9月23日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•One or both eyes having a history of non-infectious uveitis affecting the posterior segment of the eye > 1 yr requiring either systemic or sub-tenon injections of corticosteroid, study eye must be clinically quite at the time of implantation and have visual acuity of at least 1.4logMar units.

•Allergy to FA, history of only posterior segment uveitis without vitritis or macula edema, history of iritis only and no vitreous cells or haze, uveitis of infectious etiology, vitreous hemorrhage, presence of toxoplasmosis scar in study eye, peripheral retinal detachment in area of implantation, media opacity precluding ophthalmic evaluation, presence or history or uncontrolled IOP, ocular surgery within 3 months of enrollment, subjects requiring chronic systemic corticosteroid or immunosuppressive therapy for non-ocular conditions, subjects tested positive for HIV, pregnant or lactating females, females of childbearing potential considering becoming pregnant during the course of the study and not taking effective contraception, subjects whose special risks outweigh the potential benefits of participating in the study, subjects who are unlikely to comply with study protocol and visit schedule, subjects who are currently enrolled in any other IND or have participated in an IND within 1 month of enrollment.

发起方

Bausch & Lomb (Rochester)